510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250143Substantially Equivalent

Digital Prism Correction Feature (DPCF)

Apple Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250143 is the FDA 510(k) clearance record for Digital Prism Correction Feature (DPCF), a class I device, cleared for Apple, Inc. on under FDA product code SCW (Digital Prismatic Correction). FDA's definition for product code SCW reads: "The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction". FDA records list 10 510(k) clearances for Apple, Inc., from to . As of , FDA records show no recalls naming K250143.

Clearance record

Decision date
Received
(157 days to decision)
Product code
SCW Digital Prismatic Correction
Regulation
21 CFR 886.1655
Device class
Class I
Review panel
Ophthalmic
Applicant
Apple, Inc. One Apple Park Way, Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCW

Trailing 12 months

FDA records hold no clearances under product code SCW in the trailing twelve months.

FDA records show no clearances under product code SCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260